SAPIEN 3 for TAVR: Lower One-Year Mortality

Original Title: One-year clinical outcomes with SAPIEN 3 transcatheter aortic valve replacement in high risk and inoperable patients with severe aortic stenosis.

Reference: Herrmann H et al. Circulation. 2016; Epub ahead of print.

 

sapien 3Data presented at this last TCT annual meeting about the low rate of events at one year in inoperable patients with the SAPIEN 3 valve are now being confirmed by Circulation.

Published data include a multivariable analyzis confirming mild paravalvular regurgitation observed in 29.1% of patients is not associated to mortality.

One year survival rate was 85.6% in 583 high risk or inoperable patients with severe symptomatic aortic stenosis receiving the balloon expandable valve Sapien 3 (Edwards Lifesciences) in 29 centers across the USA.

Independent predictors of all cause death were major stroke (HR 10.33; CI 95% 4.62-233.09) and the use of an approach other than femoral (HR 2.06; CI 95% 1.26-3.36).

Another analyzis carried out between 30 days and a year, found that moderate paravalvular regurgitation is an independent predictor of mortality (HR 3.75; CI 95% 1.57-8.96); however, this was not true for mild regurgitation.

Comparing these figures with those of the original PARTNER trial and the initial experience of the TVT registry, we observe that mortality decreased almost 50%; even so, attributing this to an improved device may be farfetched.  Operator experience and better patient selection have certainly played an important part.

Previous studies with earlier devices had arrived to the conclusion that TAVR is an alternative to surgery in high risk patients, but today, with these new figures, we can argue for TAVR to become the standard strategy.

In line with this information, it seems reasonable now to change the indication for lower risk patients.

 

We value your opinion. You are more than welcome to leave your comments, thoughts, questions or suggestions here below.

More articles by this author

Prospective Analysis of the Feasibility of the PASCAL System for Transcatheter Mitral Repair: OneForAll Registry

Courtesy of Dr. Juan Manuel Pérez. Mitral transcatheter edge-to-edge repair (M-TEER) is an effective option for patients with severe mitral regurgitation who are at high...

Left Bundle Branch Block after TAVR: What Is Its Impact?

Courtesy of Dr. Juan Manuel Pérez. Left bundle branch block (LBBB) is a common complication following transcatheter aortic valve replacement (TAVR), which can be either...

Multicenter Experience with 3D Intracardiac Echocardiography for Guiding Interventional Cardiac Procedures

Courtesy of Dr. Juan Manuel Pérez. Imaging techniques play a fundamental role in interventional cardiac procedures. Intracardiac echocardiography (ICE) appears as an alternative to transesophageal...

Pathology of Self-Expanding Transcatheter Aortic Bioprostheses and Hypoattenuated Leaflet Thickening

Courtesy of Dr. Juan Manuel Pérez. Despite the available long term followup data on of transcatheter aortic valve replacement (TAVR), bioprosthesis durability continues under debate....

LEAVE A REPLY

Please enter your comment!
Please enter your name here

Related Articles

SOLACI Sessionsspot_img

Recent Articles

ACC 2025 | FAME 3: FFR Guided PCI vs CABG 5 Year Outcomes.

Earlier studies comparing percutaneous coronary intervention (PCI) vs coronary artery bypass graft (CABG) have shown fewer events at long term for the surgical strategy.  However,...

ACC 2025 | API-CAT: Reduced vs. Full Dose Extended Anticoagulation in Patients with Cancer Related VTE

The risk of cancer related recurrent venous thromboembolism (VTE) will drop over time, while bleeding risk will persist. At present, it is recommended we...

STRIDE: Semaglutide in Patients with Peripheral Arterial Disease and Type II Diabetes

Peripheral arterial disease (PAD) is a severe complication in patients with type II diabetes, primarily affecting peripheral vessels, especially below-the-knee (BTK) arteries. This condition...